BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL

    MDR report key: 1130124 · Received August 19, 2008

    Report

    Report Number
    9612501-2008-00043
    Event Type
    Malfunction
    Date Received
    August 19, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 6, 2008
    Manufacturer
    SANTO DOMINGO - USS
    Product Code
    GCJ
    PMA / PMN Number
    K922123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: AFTER INSERTED SPECIMEN INTO POUCH, PULLED RING, BUT SUTURE BROKE AND THE POUCH FELL INTO THE PT CAVITY. IT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER. NO TISSUE DAMAGE OR BLEEDING WAS REPORTED. PROCEDURE: PARTIAL NEPHRECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL SURGICAL SPECIMEN POUCH GCJ SANTO DOMINGO - USS J8D0032

    Patients

    Seq Age Sex Outcome Treatment
    1